Details for Patent: 10,278,923

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Which drugs does patent 10,278,923 protect, and when does it expire?

Patent 10,278,923 protects OZEMPIC, RYBELSUS, and WEGOVY, and is included in two NDAs.

This patent has thirty-six patent family members in twenty-four countries.

Summary for Patent: 10,278,923

Title:	Oral dosing of GLP-1 compounds
Abstract:	The present invention relates to improved uses of GLP-1 peptides in oral therapy.
Inventor(s):	Flemming S. Nielsen, Per Sauerberg
Assignee:	Novo Nordisk AS
Application Number:	US15/651,043
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,278,923
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

US Patent 10,278,923: Scope, Claims, Expiration, and Oral Semaglutide Patent Landscape

US Patent 10,278,923 protects once-daily oral administration of long-acting GLP-1 peptides, especially semaglutide, in a solid dosage form containing sodium N-(8-(2-hydroxybenzoyl)amino)caprylate, commonly called SNAC. The broadest practical commercial target is a tablet containing 2-40 mg semaglutide and 200-400 mg SNAC, including the marketed 300 mg SNAC configuration used in Rybelsus.

The patent is a method-of-treatment patent rather than a pure composition patent. A competing product must satisfy every limitation of an asserted claim, including the peptide identity, oral solid dosage form, SNAC or related enhancer, administration frequency, and, for some claims, the dose range.

What does US Patent 10,278,923 cover?

US 10,278,923 covers treating diabetes or obesity by orally administering a solid dosage form containing:

• A long-acting acylated GLP-1 peptide;
• An absorption enhancer that is a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid;
• A dosing schedule generally no less frequent than every second day;
• In the narrower claims, semaglutide, SNAC, and specified dose quantities.

The patent is directed principally to the oral delivery of semaglutide. Its claims combine three technically important elements:

1. Semaglutide or a closely defined long-acting GLP-1 analogue.
2. SNAC-mediated oral absorption.
3. Frequent oral dosing despite a plasma half-life of at least 60 hours.

The claims do not cover every oral GLP-1 product. They require the claimed peptide and enhancer combination, or the specifically listed peptide alternatives.

How do the independent claims differ?

The independent claims create overlapping but distinct infringement routes.

Claim	Core scope	Key narrowing limitations
1	Oral treatment of diabetes or obesity using an acylated GLP-1 analogue and a salt of SNAC-related enhancer	Peptide has three or fewer substitutions relative to native GLP-1; half-life at least 60 hours; half-life-to-dosing-interval ratio greater than 2:1
14	Oral treatment using one of two specifically identified GLP-1 peptides	Semaglutide or the specified alternative peptide; half-life at least 60 hours; SNAC; dosing every second day or more frequently
21	Oral treatment using semaglutide	SNAC; once-daily administration

Claim 1 is the broadest independent claim in peptide scope but contains the additional structural and pharmacokinetic requirements. Claim 14 is narrower because it identifies the peptide candidates expressly. Claim 21 is narrower still because it requires semaglutide and once-daily administration.

For a commercial Rybelsus-like product, claim 21 is the most direct claim. Claims 8-13, 15-20, and 22-23 add tablet, dosage, and SNAC-quantity limitations.

What are the key claim limitations?

Long-acting acylated GLP-1 peptide

Claim 1 requires an acylated GLP-1 analogue with no more than three amino-acid substitutions relative to native GLP-1(7-37). The peptide must have a human plasma half-life of at least 60 hours.

Semaglutide meets the commercial intent of this limitation. It is an acylated GLP-1 analogue incorporating Aib at position 8, Arg at position 34, and a lysine-linked fatty-acid-containing side chain. The extended half-life allows once-weekly injectable administration and supports the claimed pharmacokinetic relationship for oral dosing.

The second peptide identified in claims 2 and 14 is a separate long-acting GLP-1 analogue with a different fatty-acid-containing structure. The presence of that peptide in the claims expands protection beyond semaglutide, but its commercial relevance is materially lower because Rybelsus uses semaglutide.

SNAC enhancer

The claims require a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid. The specified commercial form is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate, or SNAC.

SNAC is not merely an excipient in the claim structure. It is a required claim element. A product using a different oral absorption enhancer could avoid literal infringement if it also avoids equivalents-based liability.

Claims 8, 19, 20, and 23 specifically require SNAC. Claims 1 and 14 use broader enhancer language that encompasses salts of the named caprylic-acid compound.

Solid oral dosage form

The independent claims require a solid oral dosage form. The dependent claims identify:

• Tablets;
• Capsules;
• Sachets;
• Granules.

The commercial formulation is a tablet. Claim 21 does not independently recite tablet form, but claims 6, 13, 18, and 23 create narrower tablet-specific positions.

A liquid oral semaglutide formulation would not literally satisfy the solid dosage-form limitation, although other patents could still apply.

Dosing frequency

Claims 3, 10, and 14 require administration every second day or more frequently. Claims 4, 11, 16, and 21 require once-daily administration.

The phrase “every second day or more frequently” covers daily dosing and potentially alternate-day dosing. It does not cover weekly oral administration.

Half-life-to-dosing-interval ratio

Claim 1 requires the ratio of the peptide’s plasma half-life in days to the dosing interval in days to exceed 2:1.

For daily dosing, the dosing interval is one day. The peptide therefore must have a plasma half-life exceeding two days to satisfy the ratio. Semaglutide’s human half-life is approximately one week, making the ratio substantially greater than 2:1. The limitation is less restrictive for semaglutide than for shorter-lived GLP-1 analogues.

This limitation may create factual disputes over:

• The applicable human half-life dataset;
• Whether the half-life must be measured in the intended patient population;
• Whether the dosing interval is measured from scheduled administration or actual administration;
• Whether a formulation that materially changes exposure has the same relevant half-life.

Which dependent claims are most relevant to Rybelsus?

The strongest product-specific cluster is claims 21-23:

Claim	Limitation
21	Semaglutide, SNAC, solid oral dosage form, once-daily treatment
22	2-40 mg semaglutide and 200-400 mg SNAC
23	300 mg SNAC

Claims 8-13 provide another commercially relevant route:

• Claim 8 requires semaglutide, SNAC, and tablet form.
• Claim 9 adds 2-40 mg semaglutide and 200-400 mg SNAC.
• Claim 11 requires once-daily dosing.
• Claim 13 requires a tablet.
• Claim 19 specifies 300 mg SNAC.

The claims do not require a particular semaglutide dose within claim 21, but claims 22 and 23 narrow the scope to the commercial dosage architecture.

What is the patent expiration date?

The expected ordinary US patent-term expiration is March 6, 2031, based on the earliest claimed priority date in the family and the standard 20-year term measured from the applicable nonprovisional filing date. The precise expiration should be confirmed against the USPTO Patent Center record and any terminal disclaimer or patent-term adjustment entry before relying on it in litigation or launch planning.

Event	Date
Earliest family priority	March 6, 2010
US patent grant	May 7, 2019
Expected ordinary expiration	March 6, 2031

A patent-term extension based on regulatory review would require a separate USPTO and FDA determination. No extension should be assumed solely from the approval of Rybelsus.

What is the Orange Book status of US 10,278,923?

US 10,278,923 has been associated with the Rybelsus regulatory patent estate and is relevant to FDA-approved oral semaglutide products. The commercial significance of the patent depends on the specific Orange Book listing, use code, and any later delisting or listing update.

For an ANDA applicant, the critical issue is whether the listed patent is subject to:

• A Paragraph IV certification;
• A Paragraph III certification;
• A section viii statement carving out the patented method;
• A 30-month stay triggered by timely patent litigation.

Because the claims cover treatment of diabetes and obesity using oral semaglutide with SNAC, a section viii carve-out may be difficult if the proposed ANDA label includes the same dosing and therapeutic uses. A generic applicant could instead challenge validity, enforceability, or noninfringement through a Paragraph IV certification.

The FDA Orange Book, not the patent document alone, controls the operative listing status for ANDA certification analysis. [1]

When does Rybelsus lose exclusivity?

Rybelsus has several layers of exclusivity:

Exclusivity layer	Practical effect
New chemical entity exclusivity	Blocks ANDA approval for the statutory NCE period
Clinical-investigation exclusivity	Depends on the approved indication and FDA listing
Orange Book patents	Can delay approval or create litigation exposure
Formulation and manufacturing patents	Can create additional barriers even after the core patent expires
Trade secrets and know-how	May complicate independent development but do not independently block an ANDA

Rybelsus was approved by FDA in September 2019. The commercial launch occurred after FDA approval and after the oral semaglutide development program established the product’s efficacy and safety profile. [2] Patent protection, rather than FDA exclusivity alone, is expected to control the earliest practical generic-entry date.

The March 2031 date associated with US 10,278,923 is not necessarily the last date on which all Rybelsus-related intellectual-property restrictions end. Other listed patents may expire later.

How strong is the patent estate for oral semaglutide?

The estate is stronger than reliance on US 10,278,923 alone would suggest. It includes multiple patent categories:

Patent category	Protected subject matter
Peptide composition	Semaglutide structure and related analogues
Oral formulation	Semaglutide with SNAC or related absorption enhancers
Dosing regimen	Daily or frequent oral administration
Therapeutic use	Diabetes, obesity, glycemic control, and weight management
Manufacturing	Peptide synthesis, purification, acylation, and formulation processes
Solid dosage form	Tablets and excipient configurations
Regulatory listing	Patents identified for FDA-approved Rybelsus uses

The principal strength of US 10,278,923 is claim convergence. A competing product may need to avoid several features at once: semaglutide, SNAC, solid oral delivery, and once-daily treatment. A design-around that changes only tablet excipients may remain exposed to the method claims.

The main weaknesses are claim-specific. The patent does not broadly cover all oral semaglutide formulations, all GLP-1 peptides, or all absorption enhancers. A product that uses a different peptide, a different enhancer, a non-solid formulation, or a materially different dosing interval may present a stronger noninfringement position.

What prior-art and validity issues are most important?

Written description and enablement

Claim 1 reaches a broad class of acylated GLP-1 analogues with a long human half-life and a specified enhancer. A challenger could argue that the specification does not adequately support the full breadth of the genus, particularly if the disclosure is concentrated on semaglutide and a limited number of examples.

Enablement arguments may focus on whether the specification teaches the full scope without undue experimentation, including:

• Multiple acylated GLP-1 analogues;
• Multiple salts of the enhancer;
• Different solid dosage forms;
• Diabetes and obesity treatment;
• The claimed pharmacokinetic relationship.

Claims 14 and 21 are less exposed to genus-breadth arguments because they identify semaglutide or a specifically named analogue.

Obviousness

A challenger could combine prior art relating to:

• Injectable long-acting GLP-1 analogues;
• Oral peptide delivery;
• SNAC and other absorption enhancers;
• Daily oral dosing;
• Semaglutide pharmacokinetics.

The patent owner’s strongest response would be evidence of unexpected oral bioavailability, clinically useful exposure, and successful daily oral treatment using SNAC. FDA approval and clinical results do not automatically establish validity, but they can support secondary-consideration arguments when tied to the claimed combination. [2, 3]

Claim construction

The most consequential claim-construction disputes are likely to concern:

• The meaning of “solid oral dosage form composition”;
• Whether the enhancer must be present in the administered product in the claimed salt form;
• The measurement of human plasma half-life;
• The calculation of the half-life-to-dosing-interval ratio;
• The scope of “every second day or more frequently”;
• Whether “therapeutically effective amount” imposes a measurable product-specific requirement.

Which companies are challenging Rybelsus patents?

Publicly identified generic challenges must be evaluated from FDA Paragraph IV notifications, ANDA litigation complaints, district-court dockets, and Novo Nordisk’s public filings. A company’s announcement of an ANDA or a patent challenge does not establish that it will launch before patent expiry.

The relevant potential challengers include large generic manufacturers with peptide manufacturing capacity and oral solid-dose capabilities. The commercial barriers are higher than for a conventional small-molecule generic because a semaglutide challenger must address:

• Peptide active-ingredient manufacture;
• Sequence and acylation control;
• Impurity profiling;
• Bioequivalence for a low-bioavailability oral peptide;
• SNAC formulation performance;
• FDA requirements for complex product characterization;
• Multiple Orange Book patents.

No conclusion about a specific company’s noninfringement position should be drawn from the existence of an ANDA alone. The decisive facts are the Paragraph IV notice, asserted patents, proposed label, and litigation outcome.

What litigation and settlement risks affect generic entry?

A timely Paragraph IV certification can trigger patent litigation and a statutory 30-month stay of FDA approval, subject to the Hatch-Waxman framework. [4] The litigation could involve:

1. Infringement of use claims covering oral semaglutide with SNAC.
2. Invalidity based on obviousness, written description, enablement, or indefiniteness.
3. Patent-term and Orange Book listing disputes.
4. Section viii label carve-out issues.
5. Settlement agreements affecting launch timing.

A settlement could permit an authorized generic, a delayed generic launch, or entry before the nominal patent expiration date. FTC review and applicable antitrust rules would be relevant to any agreement containing compensation, supply rights, or launch restrictions. [5]

How does US 10,278,923 compare with injectable semaglutide patents?

Issue	Oral semaglutide, US 10,278,923	Injectable semaglutide
Delivery	Solid oral dosage form	Subcutaneous injection
Absorption technology	Requires SNAC-related enhancer	No oral absorption enhancer required
Dosing claims	Daily or every-second-day administration	Generally weekly administration
Primary infringement risk	Product and method combination	Peptide composition, formulation, device, and use patents
Generic complexity	High because of peptide and oral bioavailability	High because of peptide, device, and biologic-like analytical complexity
Key commercial product	Rybelsus	Ozempic and Wegovy

The patents overlap at the semaglutide active-ingredient level but diverge in delivery system and therapeutic method. A competitor that avoids oral SNAC delivery may avoid this patent while remaining exposed to semaglutide composition or injectable formulation patents.

What licensing deals support the SNAC platform?

Novo Nordisk acquired Emisphere Technologies in 2020 in a transaction valued at approximately $1.8 billion. The transaction gave Novo Nordisk control of Emisphere’s oral delivery technology, including SNAC-related intellectual property and development capabilities. [6]

This transaction reduced reliance on an external SNAC licensor and consolidated the commercial position behind Rybelsus. It also increased the importance of the broader Emisphere patent portfolio when evaluating freedom to operate for oral peptide products.

What generic launch scenarios exist?

Scenario 1: Launch after patent expiry

A challenger waits until the relevant patent barriers expire, then launches an approved semaglutide/SNAC product. This minimizes litigation risk but sacrifices years of market opportunity.

Scenario 2: Paragraph IV launch

A challenger argues that US 10,278,923 and related patents are invalid, unenforceable, or not infringed. The commercial launch depends on litigation timing, court rulings, and any applicable 30-month stay.

Scenario 3: Section viii carve-out

A challenger removes patented indications or dosing instructions from its labeling. This strategy may be difficult where the asserted claims cover the core use of oral semaglutide for diabetes or obesity.

Scenario 4: Formulation design-around

A challenger uses a different enhancer, a different salt, a different dosage form, or a different schedule. This could avoid literal infringement of selected claims but may remain exposed to other formulation, composition, or manufacturing patents.

What geographic coverage does the patent estate have?

US 10,278,923 provides protection in the United States. Parallel protection may exist in Europe, Japan, China, Canada, and other jurisdictions through related national-phase or continuation filings, but patent scope, expiration, claim validity, and regulatory linkage must be assessed separately in each country.

The United States has the highest immediate commercial importance because:

• Rybelsus is a major US product;
• FDA Orange Book listing creates Hatch-Waxman litigation exposure;
• US method claims can delay ANDA approval;
• US sales carry substantial revenue value.

European and other markets use different regulatory and litigation systems. An EU patent does not automatically create an EU-wide equivalent of the US Orange Book system.

Key Takeaways

• US 10,278,923 is a method patent focused on oral semaglutide or related long-acting GLP-1 peptides combined with SNAC.
• Claims 21-23 are the most commercially relevant for Rybelsus because they require semaglutide, SNAC, once-daily administration, and, in narrower claims, 2-40 mg semaglutide with 300 mg SNAC.
• The expected ordinary US expiration date is March 6, 2031.
• The patent does not cover every oral GLP-1 product. It depends on the claimed peptide, enhancer, dosage form, dosing schedule, and pharmacokinetic limitations.
• The broader Rybelsus patent estate includes composition, formulation, dosing, manufacturing, and regulatory patents.
• The principal validity risks are obviousness, written description, enablement, and claim-construction disputes.
• SNAC ownership was consolidated under Novo Nordisk following its acquisition of Emisphere Technologies.
• Generic entry before 2031 would likely require Paragraph IV litigation, a successful design-around, or a settlement permitting earlier launch.

FAQs

Does US 10,278,923 cover Wegovy or Ozempic?

No. The claims are directed to oral solid dosage forms containing semaglutide or specified GLP-1 analogues with SNAC. Wegovy and Ozempic are injectable semaglutide products and do not literally satisfy the oral solid dosage-form and SNAC limitations.

Can a generic use semaglutide without infringing US 10,278,923?

Potentially, but avoiding infringement requires avoiding the complete combination of claimed elements. A product using semaglutide with a different enhancer, different dosage form, or different dosing schedule may have a stronger noninfringement position, subject to other patents.

Does the 300 mg SNAC limitation apply to every claim?

No. The 300 mg limitation appears in claims 19, 20, and 23. Claims 1, 14, and 21 do not require exactly 300 mg of SNAC, although they impose other limitations.

Can an ANDA applicant carve out obesity from its label?

A label carve-out may reduce exposure to obesity-specific method claims, but it may not avoid claims that cover diabetes treatment or the core oral semaglutide/SNAC regimen. The result depends on the exact Orange Book use code and proposed labeling.

Is the patent still important if another semaglutide patent expires later?

Yes. A single unexpired method or formulation patent can delay FDA approval or create launch injunction risk even when another patent has expired. Commercial freedom to launch depends on the complete patent and regulatory landscape, not one expiration date.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
2. U.S. Food and Drug Administration. (2019). Rybelsus (semaglutide) prescribing information. Novo Nordisk A/S.
3. U.S. Patent No. 10,278,923. (2019). Methods of treating diabetes and/or obesity with oral GLP-1 peptide compositions. United States Patent and Trademark Office.
4. Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. § 355(j).
5. Federal Trade Commission. (2023). Agreements filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
6. Novo Nordisk A/S. (2020). Novo Nordisk to acquire Emisphere Technologies. Company announcement.

Drugs Protected by US Patent 10,278,923

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-004	Dec 9, 2024		RX	Yes	Yes	10,278,923		Y	Y		METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-005	Dec 9, 2024		RX	Yes	Yes	10,278,923		Y	Y		METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	OZEMPIC	semaglutide	TABLET;ORAL	213051-006	Dec 9, 2024		RX	Yes	Yes	10,278,923		Y	Y		METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	Yes	10,278,923					METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	Yes	10,278,923					METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	10,278,923					METHOD OF TREATING TYPE 2 DIABETES MELLITUS

Foreign Priority and PCT Information for Patent: 10,278,923

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	13166205	May 2, 2013

International Family Members for US Patent 10,278,923

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014261336
Brazil	112015026325
Canada	2910903
Cyprus	1120730
Denmark	2991671
European Patent Office	2991671